drugset
drugset / Trial / NCT03391843

Neoadjuvant Chemotherapy Combined With Cetuximab for EGFR Wild Type Locally Advanced Rectal Cancer

NCT03391843 ↗

Phase 2 Active not recruiting 100 enrolled RenJi Hospital
NaSingle-groupOpen-labelTreatment

Summary

A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone for local advanced rectal cancer(LARC), but they did not increase the ratio of pathological complete response (pCR) which was associated with improvement of overall survival (OS). On the other hand,some clinical trials show that triple active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) combined with cetuximab for EGFR wild type metastatic colorectal cancer had more effective than double agents.Therefore,a hypothesis is the FOLFOXIRI+Cetuximab as the neoadjuvant chemotherapy regimen might improve the patient's ratio of pCR.

Timeline

Start
2017-12-01
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 500 mg/m2 —
Subject Irinotecan Small molecule 165 mg/m2 —
Subject Leucovorin Small molecule 200 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject fluorouracil Small molecule 2800 mg/m2 —

Indications

No indication recorded.